A Study of MBG453 in Combination With Hypomethylating Agents in Subjects With IPSS-R Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS). (STIMULUS-MDS1)
Myelodysplastic Syndromes
About this trial
This is an interventional supportive care trial for Myelodysplastic Syndromes focused on measuring Sabatolimab, Placebo, Phase II, MBG453, TIM-3, decitabine, azacitidine, myelodysplastic syndrome (MDS)
Eligibility Criteria
Inclusion Criteria:
- Signed informed consent must be obtained prior to participation in the study.
- Age ≥ 18 years at the date of signing the informed consent form (ICF)
Morphologically confirmed diagnosis of a myelodysplastic syndrome (MDS) based on 2016 WHO classification (Arber et al 2016) by investigator assessment with one of the following Prognostic Risk Categories, based on the International Prognostic Scoring System (IPSS-R):
- Very high
- High
- Intermediate with at least ≥ 5% bone marrow blast
- Not eligible at the time of screening, for intensive chemotherapy according to the investigator, based on local standard medical practice and institutional guidelines for treatment decisions
- Not eligible at the time of screening, for hematopoietic stem-cell transplantation (HSCT) according to the investigator, based on local standard medical practice and institutional guidelines for treatment decisions.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Exclusion Criteria:
- Prior exposure to TIM-3 directed therapy at any time. Prior therapy with immune check point inhibitors (e.g. anti-CTLA4, anti-PD-1, anti-PD-L1, or anti-PD-L2), cancer vaccines are allowed except if the drug was administered within 4 months prior to randomization.
- Previous first-line treatment for higher risk MDS with chemotherapy or any other antineoplastic agents including lenalidomide and hypomethylating agent (HMAs) such as decitabine or azacitidine.
- History of severe hypersensitivity reactions to any ingredient of the study treatment (azacitidine, decitabine or MGB453) or their excipients, or to monoclonal antibodies (mAbs).
- Currently using or used within 14 days prior to randomization of systemic, steroid therapy (> 10 mg/day prednisone or equivalent) or any immunosuppressive therapy. Topical, inhaled, nasal, ophthalmic steroids are allowed. Replacement therapy, steroids given in the context of a transfusion are allowed and not considered a form of systemic treatment.
- Investigational treatment for MDS received within 4 weeks prior to randomization. In case of a checkpoint inhibitor: 4 months minimum prior to randomization interval is necessary to allow enrollment.
- Active autoimmune disease requiring systemic therapy (e.g.corticosteroids).
- Live vaccine administered within 30 Days prior to randomization.
Other protocol-defined Inclusion/Exclusion may apply.
Sites / Locations
- City of Hope National Medical Center Medical Oncology & Therapeutic
- Yale University School of Medicine
- Dana Farber Cancer Institute Centerfor Sarcoma&BoneOncology
- The Cancer Institute of New Jersey The Cancer Institute of NJ
- Ohio State Comprehensive Cancer Center/James Cancer Hospital SC BCL201X2102C
- Mary Crowley Cancer Research
- Novartis Investigative Site
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Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
MBG453 + hypomethylating agents
Placebo + hypomethylating agents
Patients are taking MBG453 plus hypomethylating agents
Patients are taking placebo plus hypomethylating agents